Medtronic

[Harmony]

I received a letter today from a company named Medtronic. It says I had a medical device implanted called Annuloplasty Band and Mitral. To my knowledge I had minimal invasive Miltral Valve repair by Dr. Galloway at Nyu hospital on Feb 20. I was never told about implanting any devices in me. I know Dr.s Colvin and Galloway worked on the future band ring which I think is what the Annuloplasty. They sent me a ID card. I read somewhere here that people die from this. I was never told about any plastic ring being put around my mitral valve to hold it together. I would like to know who to speak to about this. I was never told about any medical device implanted in to me

 

[Cris N]

Obviously you want to check with your surgeon. Also, you are entitled to copies of all your medical records though you may have to pay a copying fee.

Though I know little about mitral valve repair I believe that using an annuloplasty band is common practice. You might want to check this: http://www.medtronic.com/cardsurgery/downloads/repair.pdf

 

[kfay]

Harmony, I'm glad to see you back and that you went through with your surgery. I hope everything went ok. I did not have a repair, but from what I have read, it is fairly common to use a ring in repairs. Obviously, if you are concerned, you need to give your Dr.'s office a call.

Kim

 

[debster913]

Hi, Harmony,

I had mitral repair in 2006. The surgeon used Medtronic's Future Band annuloplasty ring to secure my valve. I know this from speaking with my surgeon and obtaining my surgery report. I never received a letter from Medtronic about the ring. Interesting thayt you did.

I'm curious, what do you mean by "people can die from this"? Do you mean that people can die from having an annuloplasty ring? I never heard of that, and from what I know, they're standard use in valve repairs.

Anyway, I'd call your surgeon, and if you can't reach him, call your cardio for an explanation. It's frustrating when doctors make decisions/do things without telling us. Hopefully speaking to the surgeon/cardio will allay any fears you have.

Best,
Debi (debster913)

 

[ponytaila1a]

Harmony.....glad to see you back on the forum. Also glad that your surgery is over and you are doing well. I had a similar experience with a closure that was used to close my artery after my heart cath. No one told me in advance. I worried about everything from infection to the "device" breaking loose and going "straight to my heart". After the implant I was given a card to carry indicating to any medical professional that it was in my groin. I have been reassured by many, many cardio's and surgeons that it is "no big deal" and is most likely "gone" or "healed" by now. I still think of it anyway....I believe it is because it was done without my prior knowledge......the cardio considers it "routine" and did not feel the need to discuss it with me before the cath.....but to me it was (and is) a big deal. I can relate to your comments.

 

[Adrienne]

When they do a mitral valve repair these days, they almost always put on an annuloplasty ring. From everything I have read, it prolongs the duration of the repair. Besides that, within 6 months, your own cells cover the ring, so as far as I know, there does not seem to be any danger from having the ring.

 

[Jkm7]

That is how repairs of mitral valves are done, I think. Don't they all require annuloplasty ring? No reason to think you would die from that. Just the reverse. It is what saved your valve and thus your life. If it concerns you and you wish to know more, ask for the surgical report from your surgeon's office or your cardio. Surely he has a copy. Good to see you posting, Harmony.

Ponytail.... I also got a card after my angiogram to carry for 90 days saying I had the 'plug' in my groin. I was told to only carry the card for 90 days and after that it was a non-issue. Perhaps the plug dissolves? I cannot feel any residue of it now and I'm just over a year out. No lump, bump, nothing.

At the cath, they have to close the incision into the artery one way or another. The plug is far preferred to pressure for hours. It really isn't something the cardios discuss too much any more than the surgeons discuss stitches or wiring our chests or how they are closing us unless we specifically ask.

Not to worry. Highly unlikely you'll have any issue with it.

 

[Jkm7]

I have the same ring installed & as far as I know it's a non-issue. Not even worth the time worrying about it.

Do surgeons require a short course of coumadin after annuloplasty ring repair of mitral valve?

 

[catwoman]

The ring gives the around around the valve's opening more stability. Don't think you would want a repair without one.

My husband had an annuloplasty ring put in with his MV repair. I knew he would get one, thanks to this website, but I also think that Dr. Ryan mentioned as such during a consult.

I haven't checked the statement from the hospital, but it seems that I saw a ring listed on the invoice, along with the St. Jude valve. Could be wrong, though.

Do surgeons require a short course of coumadin after annuloplasty ring repair of mitral valve?

John was Rxed warfarin because of arrhythmia post-op, not because of the ring. They tried Amiodarone in the hospital, which didn't show any immediate results, so they switched to warfarin. He was on that for 7 months.

John also had one of those plugs after his heart cath. Sure beat having that horrid vise device on the incision area at the groin. Can't remember manufacturer of the plug. We were told it would dissolve within 90 days.

 

[laurad37]

I would talk to your surgeon. Annulplasty is the procedure its called when they put this ring around the leaflets of your valve to repair it. I would have imagined your dr should have discussed with you of how they were going to repair the valve.

 

[Jkm7]

I just pulled out the pamphlet they gave me and the cath plug is called Angio-Seal Vascular Closure Device. It states that 'within 60-90 days, the anchor, collagen and suture will natually be absorbed by your body.'

 

[netmiff]

I was "plugged" after my cath, as was my father after his 2; same hospital. Seems it is the way they do it these days.

As far as not being told, I think these are minor details to the surgeon, routine things that they may forget to mention - not intentionally, but just because it is so much part of the routine that they feel it is covered in saying "mitral valve repair" or whatever.

 

[Jkm7]

message deleted

 

[debster913]

Do surgeons require a short course of coumadin after annuloplasty ring repair of mitral valve?

Yes, as far as I know. I was on coumadin for six weeks after my surgery.

Again, Harmony, I wouldn't worry about complications from having an annuloplasty ring. The purpose of this ring is to secure the valve-- giving it, and you, a better life span.

 

[Jkm7]

Thank you, debster. I was unaware that like with a tissue valve replacement, a repair could necessitate a short course of coumadin.

 

[pamela]

Every device, be it tissue or not, used in your heart or body is an implant. Medtronic is simply making sure that your personal information is correct for the company's database. The manufacturers of surgical tools and devices need the records to protect themselves from litigation and have a right to know where and in whom the surgeons who do the operations and procedures have implanted them. They also keep the products they track on record to prevent the unethical re-use of some items. ie The scandal a while back regarding defibrillator recycling between patients; horrible, but true and if someone would do that, what's to stop them from reusing a mechanical valve?

 

[ponytaila1a]

I just pulled my pamphlet on the StarClose....it says nothing about 3 months...calls it a "nitinol clip" .....nothing about disolving......and yes it was on my invoice. But I agree with you...it beats the pressure thingy....it was just a worry and is ....even yesterday my surgeon told me if I wanted to carry the card to do so, but it is probably gone.....or healed....so I need to "drop it".....I should have asked about the ring.....I most likely will have one of those also.

 

[Harmony]

Before I wrote on the web site I researched Medtronic on valve replacement. There was a article written by Barry Mier on March 13 that said Medtronic Links Device for Heart to 13 deaths it was posted by Skeptic 49. I am really very angry that my Surgeon or 1 of my Cardios never told me about this. Both are away till next week so I can not get in touch with them although I have tried. I do remember reading a article many months ago that DR's Colvin and Galloway had worked on something called the future band. However it seems this future band is world wide so I dont know what to think. I am really angry to know I have had something implanted in me without my knowledge. I dont think I would have had the surgery if I had known this.

 

[debster913]

Harmony,
Please don't say you wouldn't have had the surgery if you'd known a Medtronic device was going to be in your heart. It's better to have the surgery than not at all. I know you are speaking from anger, though.

I think what you are referring to are Medtronic devices, not rings. I did some searching myself and saw nothing that said annuloplasty rings by Medtronic were causing death.

Here is an excerpt from that article:
"The new data reflect the first fatality update by Medtronic since October 2007, when it recalled the device — a thin electrical cable that connects an implanted defibrillator to a patient’s heart. The company cited five deaths when it recalled the product, saying fractures in the cable could cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart, or to fire for no reason."

This has to do with defibrillator devices, not rings. No surgeon would put anything in you that has been recalled/proven to cause death.

Here's a link to that article: http://www.nytimes.com/2009/03/14/business/14device.html?partner=rss&emc=rss

 

[Lynlw]

Before I wrote on the web site I researched Medtronic on valve replacement. There was a article written by Barry Mier on March 13 that said Medtronic Links Device for Heart to 13 deaths it was posted by Skeptic 49. I am really very angry that my Surgeon or 1 of my Cardios never told me about this. Both are away till next week so I can not get in touch with them although I have tried. I do remember reading a article many months ago that DR's Colvin and Galloway had worked on something called the future band. However it seems this future band is world wide so I dont know what to think. I am really angry to know I have had something implanted in me without my knowledge. I dont think I would have had the surgery if I had known this.

Harmony, the device with the problem are leads to defibrillators. I haven't heard of any problems with the rings they use in valve repairs. I am sorry you are so upset.